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FDA 510(k)

GYRUS ENT NERVE STIMULATOR

K-Number: K021595 · 2002-10-24

ApplicantGyrus Ent LLC
Decision Date2002-10-24
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GYRUS ENT NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 2002-10-24 under 510(k) number K021595. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ENT NERVE STIMULATOR?

GYRUS ENT NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 2002-10-24. The listed applicant is Gyrus Ent LLC. The 510(k) number is K021595.

When did GYRUS ENT NERVE STIMULATOR receive FDA 510(k) clearance?

GYRUS ENT NERVE STIMULATOR received FDA 510(k) clearance on 2002-10-24, under 510(k) number K021595.

Who is the listed applicant for GYRUS ENT NERVE STIMULATOR?

The FDA 510(k) record lists Gyrus Ent LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYRUS ENT NERVE STIMULATOR?

The FDA product code for GYRUS ENT NERVE STIMULATOR is ETN.

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Other records listing Gyrus Ent LLC as applicant

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Related Devices (Code: ETN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc.K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)Medtronic Xomed, Inc.K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)Inomed Medizintechnik GmbHK233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLCK232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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